NDA 016675

MERCK

FDA Drug Application

Application #016675

Application Sponsors

NDA 016675

MERCK

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 8MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

DECADRON-LA

DEXAMETHASONE ACETATE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1973-09-06	STANDARD
LABELING; Labeling	SUPPL	12	AP	1979-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1981-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1981-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1982-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1983-02-21	STANDARD
LABELING; Labeling	SUPPL	19	AP	1989-05-16	STANDARD
LABELING; Labeling	SUPPL	20	AP	1985-03-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1989-12-11	STANDARD
LABELING; Labeling	SUPPL	28	AP	1993-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1996-03-01	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	32	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16675
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)